Benzonatate 100mg Capsules
It is used to relieve coughing.
Drug Class
Antitussive
Pharmacologic Class
Non-narcotic antitussive; Local anesthetic
Pregnancy Category
Category C
FDA Approved
Jan 1958
DEA Schedule
Not Controlled
Overview
What is this medicine?
Benzonatate is a medication used to relieve cough. It works by numbing the cough reflex in your lungs and airways, helping to reduce the urge to cough.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. When taking your medication:
Swallow the tablet whole without chewing, breaking, opening, or dissolving it.
Do not suck on the tablet.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature, protected from light and moisture.
Keep it in a dry place, away from the bathroom.
Store all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a local drug take-back program.
Missing a Dose
If you take your medication regularly and miss a dose:
Take the missed dose as soon as you remember.
If it's almost time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
* If you take your medication as needed, do not take it more frequently than directed by your doctor.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. When taking your medication:
Swallow the tablet whole without chewing, breaking, opening, or dissolving it.
Do not suck on the tablet.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature, protected from light and moisture.
Keep it in a dry place, away from the bathroom.
Store all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a local drug take-back program.
Missing a Dose
If you take your medication regularly and miss a dose:
Take the missed dose as soon as you remember.
If it's almost time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
* If you take your medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Do not chew, crush, or dissolve the capsule. Swallow it whole. Chewing or dissolving the capsule can cause numbness in your mouth and throat, and potentially lead to choking or severe allergic reactions.
- Avoid activities requiring mental alertness, such as driving or operating machinery, until you know how this medication affects you, as it may cause drowsiness or dizziness.
- Do not exceed the prescribed dose. Taking too much can be dangerous, especially for children.
- Keep this medication out of reach of children at all times. Accidental ingestion by children can be fatal.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
100 mg three times daily
Dose Range:
100 - 200 mg
Condition-Specific Dosing:
maximumDailyDose:
600 mg/day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Contraindicated in children under 10 years of age due to risk of fatal overdose.
Adolescent:
Not established (generally not recommended for children under 10, for adolescents 10-18, consult physician, adult dosing may apply if appropriate weight/age)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
Use with caution; monitor for adverse effects
Dialysis:
Not well studied; use with caution
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
Use with caution; monitor for adverse effects
Severe:
Use with caution; monitor for adverse effects
Pharmacology
Mechanism of Action
Benzonatate acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by desensitizing them, thereby reducing the cough reflex at its source. It also has a central antitussive effect, though less prominent than its peripheral action.
Pharmacokinetics
Absorption:
Bioavailability:
Not available
Tmax:
Approximately 2 hours
FoodEffect:
Not significantly affected by food, but can be taken with food to minimize GI upset.
Distribution:
Vd:
Not available
ProteinBinding:
Not available
CnssPenetration:
Limited (primarily peripheral action, but some central effect)
Elimination:
HalfLife:
Not well-established (reported to be short, e.g., ~1 hour in some sources, but variable)
Clearance:
Not available
ExcretionRoute:
Renal (primarily)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
15-20 minutes
PeakEffect:
Not well-defined, generally within 1 hour
DurationOfAction:
3-8 hours
Safety & Warnings
BLACK BOX WARNING
Fatal Overdose in Children Under 10 Years of Age: Accidental ingestion of benzonatate by children under 10 years of age has resulted in death. Keep benzonatate out of reach of children. In case of accidental ingestion, seek medical attention immediately.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in behavior
Confusion
Hallucinations (seeing or hearing things that are not there)
Numbness and tingling of the mouth, tongue, throat, and face (especially if the medication was broken, crushed, chewed, dissolved, or sucked before taking)
+ If numbness or tingling occurs, do not eat or drink until it resolves
+ If an allergic reaction occurs or if numbness or tingling persists or worsens, contact your doctor immediately
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Constipation
Dizziness or headache
Feeling sleepy
Stuffy nose
Upset stomach
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in behavior
Confusion
Hallucinations (seeing or hearing things that are not there)
Numbness and tingling of the mouth, tongue, throat, and face (especially if the medication was broken, crushed, chewed, dissolved, or sucked before taking)
+ If numbness or tingling occurs, do not eat or drink until it resolves
+ If an allergic reaction occurs or if numbness or tingling persists or worsens, contact your doctor immediately
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Constipation
Dizziness or headache
Feeling sleepy
Stuffy nose
Upset stomach
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects.
Seek Immediate Medical Attention If You Experience:
- Difficulty breathing or swallowing (signs of allergic reaction or choking)
- Rash, hives, or itching
- Swelling of the face, lips, tongue, or throat
- Chest pain or tightness
- Confusion or hallucinations
- Severe drowsiness or dizziness
- Numbness or tingling in the mouth, throat, or face (if capsule is chewed/dissolved)
- Seizures
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose this information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose this information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before engaging in activities that require your full attention, such as driving, wait until you understand how this drug affects you.
To ensure safety, keep this medication out of the reach of children. Accidental ingestion of this drug by children under 10 years old has led to overdose and death. Signs of an overdose may include restlessness, tremors, seizures, loss of consciousness, or heart attack. If a child accidentally takes this medication, seek immediate medical attention.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Before engaging in activities that require your full attention, such as driving, wait until you understand how this drug affects you.
To ensure safety, keep this medication out of the reach of children. Accidental ingestion of this drug by children under 10 years old has led to overdose and death. Signs of an overdose may include restlessness, tremors, seizures, loss of consciousness, or heart attack. If a child accidentally takes this medication, seek immediate medical attention.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremors
- Convulsions
- Coma
- Cardiac arrest
- Respiratory arrest
What to Do:
In case of suspected overdose, seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Overdose can be fatal, especially in children.
Drug Interactions
Monitoring
Routine Monitoring
Cough frequency and severity
Frequency: Daily
Target: Reduction in cough
Action Threshold: No improvement or worsening of cough after 7 days, or development of new symptoms (e.g., fever, rash, headache)
Adverse effects (e.g., drowsiness, dizziness, GI upset, allergic reactions)
Frequency: Daily
Target: Absence or mildness of side effects
Action Threshold: Severe or persistent adverse effects, signs of hypersensitivity (rash, bronchospasm, laryngospasm), or choking sensation
Symptom Monitoring
- Cough relief
- Drowsiness
- Dizziness
- Headache
- Nausea
- Constipation
- Skin rash
- Itching
- Numbness of mouth/throat (if capsule chewed/dissolved)
- Choking sensation
- Confusion
- Hallucinations
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Trimester-Specific Risks:
First Trimester:
Potential risk, avoid if possible.
Second Trimester:
Potential risk, avoid if possible.
Third Trimester:
Potential risk, avoid if possible.
Lactation
It is not known whether benzonatate is excreted in human milk. Caution should be exercised when benzonatate is administered to a nursing woman.
Infant Risk:
Unknown; potential for sedation or other adverse effects in the infant.
Pediatric Use
Contraindicated in children under 10 years of age due to the risk of fatal overdose from accidental ingestion. For children 10 years and older, safety and efficacy have not been established, and use should be approached with extreme caution and under strict medical supervision.
Geriatric Use
Use with caution in elderly patients, as they may be more sensitive to the effects of the drug, particularly CNS effects like drowsiness and dizziness. Start with the lowest effective dose and monitor closely for adverse reactions.
Clinical Information
Clinical Pearls
- Emphasize to patients, especially parents, the critical importance of swallowing the capsule whole and keeping it out of reach of children due to the fatal overdose risk.
- Advise patients that if they experience numbness or tingling in their mouth or throat after taking the capsule, it may indicate that the capsule was chewed or dissolved, and they should seek medical attention immediately.
- Benzonatate is generally well-tolerated but can cause drowsiness or dizziness; caution patients about driving or operating machinery.
- It is a non-narcotic antitussive, making it an option when opioid-containing cough suppressants are not desired or appropriate.
- Effectiveness may vary among individuals; if cough persists or worsens after 7 days, or if new symptoms appear, advise patients to consult their healthcare provider.
Alternative Therapies
- Dextromethorphan (non-opioid antitussive)
- Codeine (opioid antitussive)
- Hydrocodone (opioid antitussive)
- Guaifenesin (expectorant, often combined with antitussives)
- Honey (for symptomatic relief of cough)
- Humidifiers
Cost & Coverage
Average Cost:
$10 - $30 per 30 capsules (100mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.